BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FULL FACE MASK

    MDR report key: 1642110 · Received March 24, 2010

    Report

    Report Number
    9611451-2010-00175
    Event Type
    Malfunction
    Date Received
    March 24, 2010
    Date of Event
    February 23, 2010
    Report Date
    February 23, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    MNT
    PMA / PMN Number
    K060044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIZE: S, LOT DATE: 090827, DATE OF MANUFACTURE: 08/27/2009, QUANTITY: 1. SIZE: M, LOT DATE: 091125, DATE OF MANUFACTURE: 11/25/2009, QUANTITY: 1. SIZE: L, LOT DATE: 090814, DATE OF MANUFACTURE: 08/14/2009, QUANTITY: 1. NO MASKS WERE RETURNED FOR EVAL, HOWEVER, AN INVESTIGATION WAS CARRIED OUT BASED ON INFO PROVIDED BY THE CUSTOMER VIA THE DISTRIBUTOR AND FISHER & PAYKEL HEALTHCARE REPRESENTATIVES. THE OXYGEN PORT CAPS ON THE RT040 MASK ARE DESIGNED TO BE REMOVABLE SO THAT AN OXYGEN LINE CAN BE ATTACHED. THESE PORT CAPS HAVE SUFFICIENT RETENTION TO REMAIN IN PLACE WITH PRESSURE INSIDE OF THE MASK DURING THERAPY. WITHOUT THE RETURN OF THE COMPLAINT MASKS, IT IS NOT POSSIBLE TO DETERMINE WHAT CAUSED THE PORT CAPS TO POP OFF OF THE MASKS. IT WAS REPORTED TO THE DISTRIBUTOR AND FISHER & PAYKEL HEALTHCARE REPRESENTATIVES THAT THE COMPLAINTS MAY BE RELATED TO USER ERROR AS IT IS POSSIBLE THAT THEY WERE REMOVED BY HOSPITAL STAFF. IT IS ALSO BE POSSIBLE THAT THE PORT CAPS POPPED OFF BECAUSE THEY HAD NOT BEEN FULLY PUSHED INTO THE MASK BASE. A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE HAS BEEN IN COMMUNICATION WITH THE HOSPITAL. THE HOSPITAL WAS INSTRUCTED TO CHECK THAT THE PORT CAPS ARE FITTED TIGHTLY INTO THE MASK BASE BEFORE USE. THE HOSPITAL REPORTED THAT THEY HAVE NOT HAD ANY FURTHER OCCURRENCES OF THIS PROBLEM. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT THE PORT CAPS CAME OFF OF A RT040 FULL FACE MASK. THE HOSPITAL ALSO REPORTED THIS COMPLAINT TO A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE. IT WAS REPORTED THAT THE PORT CAPS POPPED OFF OF A TOTAL OF THREE (3) MASKS. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FULL FACE MASK MNT FISHER & PAYKEL HEALTHCARE, LTD. RT040

    Patients

    Seq Age Sex Outcome Treatment
    1 RESPIRONICS VISION VENTILATOR| CAREFUSION AIRLIFE BREATHING CIRCUIT